NEW METHOD DEVELOPMENT AND VALIDATION OF BEMPEDOIC ACID

A Visible Spectrophotometric method has been developed and validated for the quantitative measurement of Bempedoic acid in bulk and tablet dosage forms. The process is based on the production of a colored complex in the presence of Ferric chloride between Bempedoic acid and MBTH (3-methyl-2-benzothiazolinone Hydrazone). At 663 nm the colored complex was spectrophotometrically measured. The correlation coefficient (r2) of 0.999 revealed that the approach is linear in the concentration range of 10-60 µg/mL. It was discovered that the limits of detection (LOD) and quantitation (LOQ) were 2.169 µg/mL and 6.572 µg/mL respectively. For both intra-day and inter-day precision studies the approach was proven to be precise with a percent relative standard deviation (%RSD) less than 2.0%. Recovery experiments were used to assess the method's accuracy and it was discovered that the average percentage of recovery fell between 98.0 and 102.0%. The results of the suggested approach were compared to those of the reference method for the accurate determination of Bempedoic acid in tablet dosage forms.